MAUDE Adverse Event Report: W O M WORLD OF MEDICINE GMBH AIRSEAL IFS, 230V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS2

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Event Description

International complaints reported on behalf of the customer that the device, as-ifs2, airseal ifs, 230v, was being used on (b)(6) 2023 during a coelio insufflation procedure when it was reported ¿coelio breathing at 10:40am cardiac arrest at 10:42am immediate breathing stop cardiac resuscitation/technology discharged wake up at 12:10pm.¿ the procedure was completed with an alternate airseal device, and it was reported that the patient underwent prolonged hospitalization.The current status of the patient is unknown.This report is being raised on the basis of injury due to the patient going into cardiac arrest.

Manufacturer Narrative

Evaluation found the device functioning as intended.Additionally, the pm was overdue.A device history review was not conducted as the device has been in the field more than 12 months.The service history was reviewed and found similar problems to this complaint.(b)(4).Per the instructions for use, the user is advised the following: for the safety of the patient, it is advised to start intra-abdominal insufflation with a veress needle and at the lowest flow rate (level i).Exchange the veress needle with a conventional cannula once the nominal pressure is reached and the initial insufflation phase ends.The ifu also advises the user that when the procedure is completed, stop insufflation by pressing the stop key.Airseal mode will undergo a final calibration prior to shut down.Wait for final calibration to complete prior to powering off the ifs unit.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

International complaints reported on behalf of the customer that the device, as-ifs2, airseal ifs, 230v, was being used on 02feb23 during a coelio insufflation procedure when it was reported ¿coelio breathing at 10:40am cardiac arrest at 10:42am immediate breathing stop cardiac resuscitation/technology discharged wake up at 12:10pm.¿ the procedure was completed with an alternate airseal device, and it was reported that the patient underwent prolonged hospitalization.The current status of the patient is unknown.This report is being raised on the basis of injury due to the patient going into cardiac arrest.

• Brand Name: AIRSEAL IFS, 230V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W O M WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer (Section G): W O M WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16379024
• MDR Text Key: 309578554
• Report Number: 1320894-2023-00037
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS2
• Device Lot Number: 1308CE242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Hospitalization
• Patient Ethnicity: Non Hispanic